Medical device recalls Moderate risk

Dr Franz Koehler Chemie Gmbh recalls Custodiol HTK Solution, 500ml bottle. 10 per carton.

Recall date
January 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3300-2024
FDA classification
Class II
Brand / firm
Dr Franz Koehler Chemie Gmbh
Sold / distributed
US Nationwide distribution in the state of North Carolina.

Why it was recalled

Potential for particles to be present in solution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Custodiol HTK Solution, 500ml bottle. 10 per carton.

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